Gene Electrotransfer Clinical Trials

Advances in Genetics

Volumn 89, Issue , 2015, Pages 235-262

  Heller, Richard ^a,b   Heller, Loree C ^a,b  

^a OLD DOMINION UNIVERSITY   (United States)

^b OLD DOMINION UNIVERSITY   (United States)

Author keywords

Cancer immunotherapy; Cervical cancer; Clinical trials; DNA vaccines; Electrotransfer; GET; Hantavirus; Hepatitis B; Hepatitis C; HIV; Human papillomavirus; In vivo electroporation; Melanoma; Metastatic disease; Nonviral gene therapy; Prostate cancer; Safety and tolerability; Viral vaccines

Indexed keywords

ADMINISTRATION AND DOSAGE; ANIMAL; ELECTROPORATION; GENE THERAPY; GENE TRANSFER; GENETICS; HUMAN; NEOPLASMS; PLASMID;

ANIMALS; ELECTROPORATION; GENE TRANSFER TECHNIQUES; GENETIC THERAPY; HUMANS; NEOPLASMS; PLASMIDS;

EID: 84921459183     PISSN: 00652660     EISSN: None     Source Type: Book Series    
DOI: 10.1016/bs.adgen.2014.10.006     Document Type: Article

References (83)

1. Andre F.M., Mir L.M. Nucleic acids electrotransfer in vivo: mechanisms and practical aspects. Current Gene Therapy 2010, 10(4):267-280.
2. Aurisicchio L., Mancini R., Ciliberto G. Cancer vaccination by electro-gene-transfer. Expert Review of Vaccines 2013, 12(10):1127-1137.
3. Ayuni E.L., Gazdhar A., Giraud M.N., Kadner A., Gugger M., Cecchini M., et al. In vivo electroporation mediated gene delivery to the beating heart. PLoS One 2010, 5(12):e14467.
4. Bagarazzi M.L., Yan J., Morrow M.P., Shen X., Parker R.L., Lee J.C., et al. Immunotherapy against HPV16/18 generates potent TH1 and cytotoxic cellular immune responses. Science Translational Medicine 2012, 4(155). 155ra138.
5. Belehradek M., Domenge C., Luboinski B., Orlowski S., Belehradek J., Mir L.M. Electrochemotherapy, a new antitumor treatment. First clinical phase I-II trial. Cancer 1993, 72(12):3694-3700.
6. Belehradek J., Orlowski S., Poddevin B., Paoletti C., Mir L.M. Electrochemotherapy of spontaneous mammary tumours in mice. European Journal of Cancer 1991, 27(1):73-76.
7. Bodles-Brakhop A.M., Heller R., Draghia-Akli R. Electroporation for the delivery of DNA-based vaccines and immunotherapeutics: current clinical developments. Molecular Therapy 2009, 17(4):585-592.
8. Bonamassa B., Hai L., Liu D. Hydrodynamic gene delivery and its applications in pharmaceutical research. Pharmaceutical Research 2011, 28(4):694-701.
9. Cadossi R., Ronchetti M., Cadossi M. Locally enhanced chemotherapy by electroporation: clinical experiences and perspective of use of electrochemotherapy. Future Oncology 2014, 10(5):877-890.
10. Calcedo R., Wilson J.M. Humoral immune response to AAV. Frontiers in Immunology 2013, 4:341.
11. Chi C.H., Liu I.L., Lo W.Y., Liaw B.S., Wang Y.S., Chi K.H. Hepatocyte growth factor gene therapy prevents radiation-induced liver damage. World Journal of Gastroenterology 2005, 11(10):1496-1502.
12. Chudley L., McCann K., Mander A., Tjelle T., Campos-Perez J., Godeseth R., et al. DNA fusion-gene vaccination in patients with prostate cancer induces high-frequency CD8(+) T-cell responses and increases PSA doubling time. Cancer Immunology, Immunotherapy 2012, 61(11):2161-2170.
13. Daud A.I., DeConti R.C., Andrews S., Urbas P., Riker A.I., Sondak V.K., et al. Phase I trial of Interleukin-12 plasmid electroporation in patients with metastatic melanoma. Journal of Clinical Oncology 2008, 26(36):5896-5903.
14. Dean D.A. Cell-specific targeting strategies for electroporation-mediated gene delivery in cells and animals. Journal of Membrane Biology 2013, 246(10):737-744.
15. Diaz C.M., Chiappori A., Aurisicchio L., Bagchi A., Clark J., Dubey S., et al. Phase 1 studies of the safety and immunogenicity of electroporated HER2/CEA DNA vaccine followed by adenoviral boost immunization in patients with solid tumors. Journal of Translational Medicine 2013, 11:62.
16. Diehl M.C., Lee J.C., Daniels S.E., Tebas P., Khan A.S., Giffear M., et al. Tolerability of intramuscular and intradermal delivery by CELLECTRA((R)) adaptive constant current electroporation device in healthy volunteers. Human Vaccines and Immunotherapy 2013, 9(10):2246-2252.
17. El-Kamary S.S., Billington M., Deitz S., Colby E., Rhinehart H., Wu Y., et al. Safety and tolerability of the Easy Vax clinical epidermal electroporation system in healthy adults. Molecular Therapy 2012, 20(1):214-220.
18. Eriksson F., Totterman T., Maltais A.K., Pisa P., Yachnin J. DNA vaccine coding for the rhesus prostate specific antigen delivered by intradermal electroporation in patients with relapsed prostate cancer. Vaccine 2013, 31(37):3843-3848.
19. Ferraro B., Cruz Y.L., Baldwin M., Coppola D., Heller R. Increased perfusion and angiogenesis in a hindlimb ischemia model with plasmid FGF-2 delivered by noninvasive electroporation. Gene Therapy 2010, 17(6):763-769.
20. Ferraro B., Cruz Y.L., Coppola D., Heller R. Intradermal delivery of plasmid VEGF(165) by electroporation promotes wound healing. Molecular Therapy 2009, 17(4):651-657.
21. Fioretti D., Iurescia S., Fazio V.M., Rinaldi M. In vivo DNA electrotransfer for immunotherapy of cancer and neurodegenerative diseases. Current Drug Metabolism 2013, 14(3):279-290.
22. Gothelf A., Gehl J. Gene electrotransfer to skin; review of existing literature and clinical perspectives. Current Gene Therapy 2010, 10(4):287-299.
23. Hargrave B., Downey H., Strange R., Murray L., Cinnamond C., Lundberg C., et al. Electroporation-mediated gene transfer directly to the swine heart. Gene Therapy 2013, 20(2):151-157.
24. Hart S.L. Multifunctional nanocomplexes for gene transfer and gene therapy. Cell Biology and Toxicology 2010, 26(1):69-81.
25. Heller R., Cruz Y., Heller L.C., Gilbert R.A., Jaroszeski M.J. Electrically mediated delivery of plasmid DNA to the skin, using a multielectrode array. Human Gene Therapy 2010, 21(3):357-362.
26. Heller L.C., Heller R. In vivo electroporation for gene therapy. Human Gene Therapy 2006, 17(9):890-897.
27. Heller R., Jaroszeski M., Atkin A., Moradpour D., Gilbert R., Wands J., et al. In vivo gene electroinjection and expression in rat liver. FEBS Letters 1996, 389(3):225-228.
28. Heller R., Jaroszeski M.J., Reintgen D.S., Puleo C.A., DeConti R.C., Gilbert R.A., et al. Treatment of cutaneous and subcutaneous tumors with electrochemotherapy using intralesional bleomycin. Cancer 1998, 83(1):148-157.
29. Heller L., Merkler K., Westover J., Cruz Y., Coppola D., Benson K., et al. Evaluation of toxicity following electrically mediated interleukin-12 gene delivery in a B16 mouse melanoma model. Clinical Cancer Research 2006, 12(10):3177-3183.
30. Heller L.C., Heller R. Electroporation Gene Therapy Preclinical and Clinical Trials for Melanoma. Curr Gene Ther 2010, 10:312-317.
31. Hooper J.W., Moon J.E., Paolino K.M., Newcomer R., McLain D.E., Josleyn M., et al. A Phase 1 clinical trial of Hantaan virus and Puumala virus M-segment DNA vaccines for haemorrhagic fever with renal syndrome delivered by intramuscular electroporation. Clinical Microbiology and Infection 2014, 20(Suppl. 5):110-117.
32. Jaichandran S., Yap S.T., Khoo A.B., Ho L.P., Tien S.L., Kon O.L. In vivo liver electroporation: optimization and demonstration of therapeutic efficacy. Human Gene Therapy 2006, 17(3):362-375.
33. Kalams S.A., Parker S.D., Elizaga M., Metch B., Edupuganti S., Hural J. Safety and comparative immunogenicity of an HIV-1 DNA vaccine in combination with plasmid interleukin 12 and impact of intramuscular electroporation for delivery. Journal of Infectious Diseases 2013, 208(5):818-829. for the, Niaid HIV Vaccine Trials Network.
34. Kaufmann K.B., Buning H., Galy A., Schambach A., Grez M. Gene therapy on the move. EMBO Molecular Medicine 2013, 5(11):1642-1661.
35. Kawakami S., Higuchi Y., Hashida M. Nonviral approaches for targeted delivery of plasmid DNA and oligonucleotide. Journal of Pharmaceutical Sciences 2008, 97(2):726-745.
36. Keane-Myers A.M., Bell M. Evolution of electroporated DNA vaccines. Methods in Molecular Biology 2014, 1121:269-278.
37. Kopycinski J., Cheeseman H., Ashraf A., Gill D., Hayes P., Hannaman D., et al. A DNA-based candidate HIV vaccine delivered via in vivo electroporation induces CD4responses toward the alpha4beta7-binding V2 loop of HIV gp120 in healthy volunteers. Clinical and Vaccine Immunology 2012, 19(9):1557-1559.
38. Kreiss P., Bettan M., Crouzet J., Scherman D. Erythropoietin secretion and physiological effect in mouse after intramuscular plasmid DNA electrotransfer. Journal of Gene Medicine 1999, 1(4):245-250.
39. Kutzler M.A., Weiner D.B. DNA vaccines: ready for prime time?. Nature Reviews Genetics 2008, 9(10):776-788.
40. Lavigne M.D., Gorecki D.C. Emerging vectors and targeting methods for nonviral gene therapy. Expert Opinion on Emerging Drugs 2006, 11(3):541-557.
41. Lee P.Y., Chesnoy S., Huang L. Electroporatic delivery of TGF-beta1 gene works synergistically with electric therapy to enhance diabetic wound healing in db/db mice. Journal of Investigative Dermatology 2004, 123(4):791-798.
42. Lin X., Dean D.A. Gene therapy for ALI/ARDS. Critical Care Clinics 2011, 27(3):705-718.
43. Low L., Mander A., McCann K.J., Dearnaley D., Tjelle T.E., Mathiesen I., et al. DNA vaccination with electroporation induces increased antibody responses in patients with prostate cancer. Human Gene Therapy 2009, 20(11):1269-1278.
44. Lucas M.L., Heller R. IL-12 gene therapy using an electrically mediated nonviralapproach reduces metastatic growth of melanoma. DNA and Cell Biology 2003, 22(12):755-763.
45. Lucas M.L., Heller L., Coppola D., Heller R. IL-12 plasmid delivery by in vivo electroporation for the successful treatment of established subcutaneous B16.F10 melanoma. Molecular Therapy 2002, 5(6):668-675.
46. Marshall W.G., Boone B.A., Burgos J.D., Gografe S.I., Baldwin M.K., Danielson M.L., et al. Electroporation-mediated delivery of a naked DNA plasmid expressing VEGF to the porcine heart enhances protein expression. Gene Therapy 2010, 17(3):419-423.
47. Marti G., Ferguson M., Wang J., Byrnes C., Dieb R., Qaiser R., et al. Electroporative transfection with KGF-1 DNA improves wound healing in a diabetic mouse model. Gene Therapy 2004, 11(24):1780-1785.
48. Marti G.P., Mohebi P., Liu L., Wang J., Miyashita T., Harmon J.W. KGF-1 for wound healing in animal models. Methods in Molecular Biology 2008, 423:383-391.
49. Martin J.B., Young J.L., Benoit J.N., Dean D.A. Gene transfer to intact mesenteric arteries by electroporation. Journal of Vascular Research 2000, 37(5):372-380. 25753.
50. Matthiessen L.W., Chalmers R.L., Sainsbury D.C., Veeramani S., Kessell G., Humphreys A.C., et al. Management of cutaneous metastases using electrochemotherapy. Acta Oncologica 2011, 50(5):621-629.
51. Mingozzi F., High K.A. Immune responses to AAV vectors: overcoming barriers to successful gene therapy. Blood 2013, 122(1):23-36.
52. Mir L.M., Glass L.F., Sersa G., Teissie J., Domenge C., Miklavcic D., et al. Effective treatment of cutaneous and subcutaneous malignant tumours by electrochemotherapy. British Journal of Cancer 1998, 77(12):2336-2342.
53. Mir L.M., Orlowski S., Belehradek J., Paoletti C. Electrochemotherapy potentiation of antitumour effect of bleomycin by local electric pulses. European Journal of Cancer 1991, 27(1):68-72.
54. Neumann E., Schaefer-Ridder M., Wang Y., Hofschneider P.H. Gene transfer into mouse lyoma cells by electroporation in high electric fields. EMBO Journal 1982, 1(7):841-845.
55. Niidome T., Huang L. Gene therapy progress and prospects: nonviral vectors. Gene Therapy 2002, 9(24):1647-1652.
56. Nishi T., Yoshizato K., Yamashiro S., Takeshima H., Sato K., Hamada K., et al. High-efficiency in vivo gene transfer using intraarterial plasmid DNA injection following in vivo electroporation. Cancer Research 1996, 56(5):1050-1055.
57. Niu G., Heller R., Catlett-Falcone R., Coppola D., Jaroszeski M., Dalton W., et al. Gene therapy with dominant-negative Stat3 suppresses growth of the murine melanoma B16 tumor in vivo. Cancer Research 1999, 59(20):5059-5063.
58. Noble M.L., Kuhr C.S., Graves S.S., Loeb K.R., Sun S.S., Keilman G.W., et al. Ultrasound-targeted microbubble destruction-mediated gene delivery into canine livers. Molecular Therapy 2013, 21(9):1687-1694.
59. Okino M., Mohri H. Effects of a high-voltage electrical impulse and an anticancer drug on in vivo growing tumors. Japanese Journal of Cancer Research 1987, 78(12):1319-1321.
60. Pinyon J.L., Tadros S.F., Froud K.E., Wong A.C.Y., Tompson I.T., Crawford E.N., et al. Close-field electroporation gene delivery using the cochlear implant electrode array enhances the bionic ear. Science Translational Medicine 2014, 6(233). 233ra254.
61. Rizzuto G., Cappelletti M., Maione D., Savino R., Lazzaro D., Costa P., et al. Efficient and regulated erythropoietin production by naked DNA injection and muscle electroporation. Proceedings of the National Academy of Sciences USA 1999, 96(11):6417-6422.
62. Sakai M., Nishikawa M., Thanaketpaisarn O., Yamashita F., Hashida M. Hepatocyte-targeted gene transfer by combination of vascularly delivered plasmid DNA and in vivo electroporation. Gene Therapy 2005, 12(7):607-616.
63. Sardesai N.Y., Weiner D.B. Electroporation delivery of DNA vaccines: prospects for success. Current Opinion in Immunology 2011, 23(3):421-429.
64. Schambach A., Zychlinski D., Ehrnstroem B., Baum C. Biosafety features of lentiviral vectors. Human Gene Therapy 2013, 24(2):132-142.
65. Song S., Shen Z., Chen L., Brayman A.A., Miao C.H. Explorations of high-intensity therapeutic ultrasound and microbubble-mediated gene delivery in mouse liver. Gene Therapy 2011, 18(10):1006-1014.
66. Spanggaard I., Snoj M., Cavalcanti A., Bouquet C., Sersa G., Robert C., et al. Gene electrotransfer of plasmid antiangiogenic metargidin peptide (AMEP) in disseminated melanoma: safety and efficacy results of a phase I first-in-man study. Human Gene Therapy Clinical Development 2013, 24(3):99-107.
67. Suda T., Liu D. Hydrodynamic gene delivery: its principles and applications. Molecular Therapy 2007, 15(12):2063-2069.
68. Titomirov A.V., Sukharev S., Kistanova E. In vivo electroporation and stable transformation of skin cells of newborn mice by plasmid DNA. Biochimica et Biophysica Acta 1991, 1088(1):131-134.
69. Touchard E., Berdugo M., Bigey P., El Sanharawi M., Savoldelli M., Naud M.C., et al. Suprachoroidal electrotransfer: a nonviral gene delivery method to transfect the choroid and the retina without detaching the retina. Molecular Therapy 2012, 20(8):1559-1570.
70. Touchard E., Bloquel C., Bigey P., Kowalczuk L., Jonet L., Thillaye-Goldenberg B., et al. Effects of ciliary muscle plasmid electrotransfer of TNF-alpha soluble receptor variants in experimental uveitis. Gene Therapy 2009, 16(7):862-873.
71. Touchard E., Kowalczuk L., Bloquel C., Naud M.C., Bigey P., Behar-Cohen F. The ciliary smooth muscle electrotransfer: basic principles and potential for sustained intraocular production of therapeutic proteins. Journal of Gene Medicine 2010, 12(11):904-919.
72. Vannucci L., Lai M., Chiuppesi F., Ceccherini-Nelli L., Pistello M. Viral vectors: a look back and ahead on gene transfer technology. New Microbiologica 2013, 36(1):1-22.
73. Vasan S., Hurley A., Schlesinger S.J., Hannaman D., Gardiner D.F., Dugin D.P., et al. In vivo electroporation enhances the immunogenicity of an HIV-1 DNA vaccine candidate in healthy volunteers. PLoS One 2011, 6(5):e19252.
74. Vasan S., Schlesinger S.J., Chen Z., Hurley A., Lombardo A., Than S., et al. Phase 1 safety and immunogenicity evaluation of ADMVA, a multigenic, modified vaccinia Ankara-HIV-1 B'/C candidate vaccine. PLoS One 2010, 5(1):e8816. 10.1371/journal.pone.0008816.
75. Wallace M., Evans B., Woods S., Mogg R., Zhang L., Finnefrock A.C., et al. Tolerability of two sequential electroporation treatments using MedPulser DNA delivery system (DDS) in healthy adults. Molecular Therapy 2009, 17(5):922-928.
76. Wang W., Li W., Ma N., Steinhoff G. Non-viral gene delivery methods. Current Pharmaceutical Biotechnology 2013, 14(1):46-60.
77. Weiland O., Ahlen G., Diepolder H., Jung M.C., Levander S., Fons M., et al. Therapeutic DNA vaccination using in vivo electroporation followed by standard of care therapy in patients with genotype 1 chronic hepatitis C. Molecular Therapy 2013, 21(9):1796-1805. 10.1038/mt.2013.119.
78. Wirth T., Parker N., Yla-Herttuala S. History of gene therapy. Gene 2013, 525(2):162-169. 10.1016/j.gene.2013.03.137.
79. Yang F.Q., Yu Y.Y., Wang G.Q., Chen J., Li J.H., Li Y.Q., et al. A pilot randomized controlled trial of dual-plasmid HBV DNA vaccine mediated by in vivo electroporation in chronic hepatitis B patients under lamivudine chemotherapy. Journal of Viral Hepatitis 2012, 19(8):581-593. 10.1111/j.1365-2893.2012.01589.x.
80. Yuan J., Ku G.Y., Adamow M., Mu Z., Tandon S., Hannaman D., et al. Immunologic responses to xenogeneic tyrosinase DNA vaccine administered by electroporation in patients with malignant melanoma. Journal of Immunotherapy of Cancer 2013, 1:20. 10.1186/2051-1426-1-20.
81. Zhang L., Rabussay D.P. Clinical evaluation of safety and human tolerance of electrical sensation induced by electric fields with non-invasive electrodes. Bioelectrochemistry 2002, 56(1-2):233-236.
82. Zhou R., Norton J.E., Zhang N., Dean D.A. Electroporation-mediated transfer of plasmids to the lung results in reduced TLR9 signaling and inflammation. Gene Therapy 2007, 14(9):775-780.
83. Zupanic A., Ribaric S., Miklavcic D. Increasing the repetition frequency of electric pulse delivery reduces unpleasant sensations that occur in electrochemotherapy. Neoplasma 2007, 54(3):246-250.